Urine Metabolites in the Diagnosis of Disease

Luventix, Inc.

Status: Enrolling

Conditions: Celiac Disease; Crohn Disease; Small Intestinal Bacterial Overgrowth Syndrome (SIBO); Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06710067

20242000 (Other Identifier)

Luventix-001

Details and patient eligibility

About

The goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases.

This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn's disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease.

The main questions it aims to answer are:

1. Does the platform identify a disease signal within each disease cohort, compared to normal controls?
2. How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?

Enrollment: 1,250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years of age at time of enrollment.
• Able and willing to provide a one-time urine sample and comply with all study procedures for the study.
• Able to understand the study procedures, able to provide consent to participate in the study, and willing to authorize release of relevant protected health information by consenting to a HIPAA medical release form.

Exclusion criteria

• Known to be pregnant.
• A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.

Trial design

1,250 participants in 1 patient group

Disease Cohort